Actively Recruiting
Clinical and Economic Comparison of 2 Methods of Intubation Tube Fixation in the Intensive Care Unit: Benefits of Intubation Tube Fixation with AnchorFastTM Versus Current Cord Fixation
Led by Hopital Foch · Updated on 2025-02-12
250
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two methods of fixing intubation tubes in patients admitted to intensive care units who require orotracheal intubation. This study aims to compare the AnchorFast device with the current cord fixation method to see if AnchorFast reduces complications such as pressure ulcers, tube mobilization, and ventilator-associated pneumonia (VAP). The study also looks at caregiver workload and satisfaction to help improve patient care and safety. The study compares two groups: one using the traditional Tensoplast white cord and elastic plaster fixation, and the other using the AnchorFast device, a single-use medical device designed to provide better oral access and reduce pressure points. Caregivers will follow specific protocols for tube care and will assess their workload and comfort with each fixation method through questionnaires. The study is designed as a real-life, non-randomized trial lasting 16 months. Participants will be regularly monitored for pressure sores, tube stability, accidental extubation, VAP occurrence, and other intubation-related complications. Caregiver workload and comfort will be evaluated using the Nursing Activity Score. The study will also analyze the budgetary impact by comparing total costs, including consumables and labor. The total duration of the study assessments is 16 months, and caregivers play an active role in data collection and evaluation.
CONDITIONS
Brief Title
Clinical and Economic Comparison of 2 Methods of Intubation Tube Fixation : AnchorFastTM Versus Current Cord Fixation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient over 18 years old
- Patient with orotracheal intubation
- Patient intubated no more than 24 hours previously
- Oral consent from patient, trusted support person or relative if unable to consent
- Membership of a French health insurance scheme
You will not qualify if you...
- Pre-existing facial, labial or auricular skin lesions
- Pre-existing mucositis
- Patients extubated for more than 24 hours whose condition requires a new intubation tube
- Nasotracheal intubation
- Planned early tracheotomy
- Patient with occipital craniectomy
- Patient in ventral position
- Pregnant or breast-feeding woman
- Patient deprived of liberty or under guardianship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 16 months
Participants receive intubation tube fixation using either the AnchorFast device or the current cord fixation method while in the intensive care unit. Caregivers perform tube care and assess workload and comfort for each fixation type.
Visits occur as needed during ICU stay to manage tube fixation and perform assessments
Duration - Up to 16 months
Participants are monitored for complications related to intubation tube fixation such as pressure sores, tube mobilization, accidental extubation, ventilator-associated pneumonia, and other intubation-related issues.
Assessments occur throughout the study period to evaluate patient safety and outcomes
Trial Site Locations
Total: 1 location
1
Hôpital Foch
Suresnes, France, 92150
Actively Recruiting
Research Team
M
Marisa LAGOA PINTO
M
Marjolaine NGOLLO, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
3
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